NOVAVAX Reports Additional Positive Data from Its Trivalent Seasonal Influenza (VLP) Vaccine Clinical Study in Healthy Adults
Novavax reported safety and hemagglutination inhibition (HAI) antibody titers from this study in a poster presentation at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA). In addition to the HAI titers, functional antibody against the Neuraminidase enzyme was measured in the sera of immunized subjects using a neuraminidase inhibition assay (NAI) developed by Novavax scientists. Inhibition of neuraminidase activity may be important in reducing the spread of influenza virus down the respiratory tract and severe influenza disease. Since neuraminidase mutates less rapidly than hemagglutinin(HA), the antibody against neuraminidase may be more effective in protecting against drifted seasonal strains or new, emerging strains of influenza virus.
In continued evaluation of the May 2009 clinical study, Novavax tested volunteers for NAI against H3N2/Brisbane and B/Florida components of the vaccine before and after immunization. The results showed that 50 to 73% of the volunteers immunized with the Novavax VLP vaccine had a 4-fold increase in the antibody that blocks neuraminidase activity. In contrast, only 1 of 19 volunteers that received the TIV showed a 4-fold rise for NAI. There was no 4-fold rise in volunteers that received placebo.
"These are very exciting results which not only support continued development of novel VLP vaccines against influenza but also provides a cornerstone to potentially differentiate our vaccine from the current standard of care," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax. "We will continue to evaluate NAI responses in additional clinical trials particularly in the ongoing study in the elderly and work to optimize the NA activity required in our vaccine to maximize NAI responses. We believe these new data reinforce our long standing thesis that VLP influenza vaccines have the potential to induce broad immunity that could lead to meaningful reduction in the burden of disease," said Dr. Singhvi.
Dr Singhvi presented these new data today in New York city at the BIO CEO Conference. Further details can be found on the corporate website at http://www.novavax.com.
Novavax, Inc.is a clinical-stage biotechnology company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.
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SOURCE Novavax, Inc.